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Device Statement

The somo·v, somo·v Platinum and Invenia ABUS are prescription medical devices that are limited to sale, distribution, or use by or on the order of a physician.
The somo·v and Invenia ABUS are indicated for a supplemental examination in addition to mammography for breast cancer in women who have dense breast tissues, no prior breast interventions, no symptoms of cancer and where mammography findings are normal or benign. The devices are intended to increase breast cancer detection and may also be used for diagnostic ultrasound imaging of the breast in women with symptoms. See your doctor for more information on automated breast ultrasound examinations.

The somo·v Platinum ABUS is intended to be used for diagnostic ultrasound breast exams solely.
The information on this website is not medical advice and is for general information purposes only. The information on this website should not be relied upon as a substitute for consultations with qualified healthcare professionals.

© 2014 General Electric Company

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